A protocol standard was developed by the National Institute of Health and Transcelerate that sought to augment clinical trial sponsors and investigators by offering a baseline for superior protocol writing—by establishing a framework for a common protocol authoring approach. The NIH’s “e-Protocol Writer” now is in use by up to 2,400 users actively developing protocols, thanks to this online tool that guides protocol collaborators through the authoring process and ensuring that they follow authority guidelines and best practices from NIH and the FDA to ICH E6 and E8.

The NIH notes one can think of it as the “Turbo Tax for clinical protocols,” reports WCG CenterWatchTrialSite News includes the link to the tool as well as to a nice summary via WCG CenterWatch’s Colin Stoecker.  

Source: e-Protocol

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